SHS_492444 GILC CROK 18157

The Impact of a Gravity versus Vacuum Based Indwelling Tunneled Pleural Drainage System on Pain: A Multicenter, Randomized Trial

Inclusion Criteria:

Clinical indications for placement of IPC for malignant pleural effusion

a. Pleural effusion with symptomatic improvement in dyspnea after drainage of ipsilateral effusion

Clinically confident symptomatic malignant pleural effusion

Histocytological proof of pleural malignancy
Recurrent large pleural effusion in context of histologically proven cancer outside the pleural space
Plans for placement of IPC within ten days of enrollment
Age > 17 years
Sufficient fluid on ultrasound to allow for safe insertion of IPC
Exclusion Criteria:

Recent (less than 60 days) thoracic surgery or chest trauma causing chronic pain
Pregnant or lactating mothers
Previous ipsilateral chemical pleurodesis
Current contralateral indwelling pleural catheter
Known rib or thoracic skeletal metastasis causing pain
Concern for active pleural infection
Respiratory failure
Irreversible bleeding diathesis
Inability to provide care for indwelling tunneled pleural catheter
Significantly loculated pleural space precluding drainage of pleural space, for which IPC alone will likely not offer symptomatic benefit
Estimated life expectancy of < 30 days (however, active enrollment in hospice program is not an exclusion criteria)
Inability to read/understand/write in the English language
Inability to follow-up for appointments/protocol
Subject has any clinical condition, diagnosis, or social circumstance that, in the opinion of the investigator would mean participation in the study would be contraindicated.
Enrollment in alternative pleural catheter trial that would preclude enrollment within this trial
Christopher Gilbert
Rocket Medical plc
Renae Koepke
  • Swedish Medical Center